Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The present study should investigate the influence of a capsular tension ring on postoperative rotational stability of a plate haptic hydrophilic acrylic intraocular lens. All patients will be operated on both eyes in one occasion. Both eyes receive a Zeiss 409MP plate haptic intraocular lens, while only on eye receives an additional capsular tension ring. Follow up visits take place 1 hour, 1 week, 1 month and 4 to 7 months after surgery. At the follow up visits, the actual IOL axis will be determined by retroillumination photography. IOL centration and tilt will be determined by anterior segment SS-OCT Casia II. IOLs will be implanted in 4 different axis 0 +/- 10 degrees, 45 +/- 10 degrees, 90 +/- 10 degrees, 135 +/- 10 degrees. IOL rotation, decentration and tilt then will be compared intraindividually.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axis 0 | Experimental | IOL Implantation at the 0 +/- 10 degrees axis |
|
| Axis 45 | Experimental | IOL Implantation at the 45 +/- 10 degrees axis |
|
| Axis 90 | Experimental | IOL Implantation at the 90 +/- 10 degrees axis |
|
| Axis 135 | Experimental | IOL Implantation at the 135 +/- 10 degrees axis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of an intraocular lens | Device | Implantation of an intraocular lens Zeiss 409 MP into the capsular bag using an injector, after removing of the human crystalline lens. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of axial intraocular lens position | Change in axis position of an intraocular lens Zeiss 409 MP from end of surgery (baseline axis) to 1 hour, 1 week, 1 month and 4-7 months (end of study visit). The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°) | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Decentration | Decentration of the intraocular lens will be measured with the Casia 2 OCT. Decentration will be described as "Decentration in millimeter" | 7 months |
| Tilt | Tilt of the intraocular lens will be measured with the Casia 2 OCT. Tilt will be described as "Tilt in degrees at a certain axis" |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna Allgemeines Krankenhaus | Recruiting | Vienna | 1090 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigator will be masked to which axis the IOL will be implanted until a sealed envelope will be opened in the operating theater.
| 7 months |
| Anterior chamber depth | The anterior chamber depth (Axial position of the IOL) of the intraocular lens will be measured with the Casia 2 OCT after 1 month. The anterior chamber depth will be measured in millimeter | 7 months |
| Best corrected visual acuity (BCVA) | BCVA will be measured at 1 week, 1 month and 4 to 7 months. The BCVA will be described as the minimum angle of resolution (logMar) | 7 months |